Equipping People To Make Sense Of What They Are Told
Clinical Trials
The cost of bringing a new drug through its various stages, that is from its discovery
through research until it might be available on the NHS may be as high as £500 million.
Several thousands of compounds are being researched at any one time from which only
a handful will develop into a medication with a very real benefit and make it onto
the world wide health systems, the path of research and proving a drug follows many
stages.
Stage 1 Research.
Usually amongst natural substances ~ plants ~ fungus ~ flowers ~ foodstuffsstuffs
etc. Seeking chemicals that have potential curative actions.
Stage 2 Uncovering Effect.
Analysing and testing of potential pharmaceuticals in the laboratory, separating
potential compounds from useless compounds. Asking “do the seemingly potential compounds
in a test tube have an effect against disorder”?
Stage 3 Pre Clinical Work.
When chemicals are considered to have potential as a pharmaceutical they are then
developed into a drug, it is a long and expensive process that leads to establishing
a formula which is easily administered and is stable. Extensive animal studies take
place at this stage. Once permission has been received for the compound to be tested
in the human body it moves into three trial phases.
A small number of human volunteers are injected with various strengths of the proposed
new medication under strict protocols.
Its purpose is not to discover whether the medication works but to study whether
it is safe and how it reacts in the human body, how long it remains in the body and
if there are any side / Serious effects.
Healthy human volunteers are recruited for this stage.
Stage 5 Phase 2 Clinical Trial.
The medication is then trialed on a number of sufferers of the disorder the drug
is designed to treat.
This is to assess whether the medication really does help the disorder, to what extent
and what dosages will be required.
Stage 6 Phase 3 Clinical Trial.
A larger trial is now undertaken amongst a greater number of sufferers recruited
with the particular disorder undergoing investigation, usually held over a year to
two years, some receive a placebo, some receive the medication, detailed information
regarding those on the trial is scrupulously recorded the observations being;